Guest guest Posted April 22, 2004 Report Share Posted April 22, 2004 Schering-Plough Submits New Drug Application (J-NDA) in Japan for PEG-INTRON® and REBETOL® Combination Therapy for Hepatitis C KENILWORTH, N.J., April 21 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that Schering-Plough K.K., the company's subsidiary in Japan, has submitted a New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) seeking marketing approval for PEG-INTRON® (peginterferon alfa-2b) Powder for Injection for use in combination with REBETOL® (ribavirin) Capsules for the treatment of chronic hepatitis C. The MHLW will provide a priority review of the application. If approved, PEG-INTRON and REBETOL will be the first and only pegylated interferon-based combination therapy approved in Japan for treating chronic hepatitis C. Hepatitis C is estimated to affect some 2 million people in Japan, according to MHLW. It is the leading cause in Japan of chronic liver disease, cirrhosis and hepatocellular carcinoma, and is associated with more than 30,000 deaths there annually. Hepatitis C is the most common reason for liver transplant in major world markets, including Japan, according to a study conducted by the World Health Organization (WHO). Schering-Plough K.K. currently markets REBETOL in Japan for use in combination with INTRON® A (interferon alfa-2b, recombinant) Injection for chronic hepatitis C. INTRON A also is approved in Japan for use as monotherapy for hepatitis C, hepatitis B and several cancer indications. PEG-INTRON is a longer-acting form of INTRON A that uses proprietary PEG technology developed by Enzon, Inc. (Nasdaq: ENZN) of Bridgewater, N.J. PEG-INTRON, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy that is designed to achieve an effective balance between antiviral activity and elimination half-life. Schering-Plough holds an exclusive worldwide license to PEG-INTRON. INTRON A is a recombinant version of naturally occurring alpha interferon, which has been shown to exert both antiviral and immunomodulatory effects. Schering-Plough markets INTRON A for 16 major antiviral and anticancer indications worldwide. REBETOL is an oral formulation of ribavirin, a synthetic nucleoside analog. Schering-Plough has worldwide rights to market oral ribavirin for hepatitis C through a licensing agreement with Valeant Pharmaceuticals International (NYSE: VRX), formally ICN Pharmaceuticals, of Costa Mesa, Calif. DISCLOSURE NOTICE: The information in this press release includes certain " forward-looking " statements concerning PEG-INTRON and the regulatory process in Japan, the market for drugs to treat hepatitis C and Schering-Plough's products. Forward-looking statements are subject to risks and uncertainties, which may cause actual results to differ materially. These risks and uncertainties include product availability, current and future branded, generic and OTC competition, the regulatory process for new products and new indications, market acceptance of new products and new indications, timing of trade buying, and patent positions. For further details and a discussion of these and other risks and uncertainties, see the company's past and future Securities and Exchange Commission filings, including the company's 2003 10-K filed Feb. 26, 2004. Schering-Plough K.K., based in Osaka, is a wholly owned subsidiary of Schering-Plough Corporation, a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide. SOURCE Schering-Plough Corporation Web Site: http://www.schering-plough.com Company News On Call: Company News On-Call: http://www.prnewswire.com/comp/777050.html Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 22, 2004 Report Share Posted April 22, 2004 Schering-Plough Submits New Drug Application (J-NDA) in Japan for PEG-INTRON® and REBETOL® Combination Therapy for Hepatitis C KENILWORTH, N.J., April 21 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that Schering-Plough K.K., the company's subsidiary in Japan, has submitted a New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) seeking marketing approval for PEG-INTRON® (peginterferon alfa-2b) Powder for Injection for use in combination with REBETOL® (ribavirin) Capsules for the treatment of chronic hepatitis C. The MHLW will provide a priority review of the application. If approved, PEG-INTRON and REBETOL will be the first and only pegylated interferon-based combination therapy approved in Japan for treating chronic hepatitis C. Hepatitis C is estimated to affect some 2 million people in Japan, according to MHLW. It is the leading cause in Japan of chronic liver disease, cirrhosis and hepatocellular carcinoma, and is associated with more than 30,000 deaths there annually. Hepatitis C is the most common reason for liver transplant in major world markets, including Japan, according to a study conducted by the World Health Organization (WHO). Schering-Plough K.K. currently markets REBETOL in Japan for use in combination with INTRON® A (interferon alfa-2b, recombinant) Injection for chronic hepatitis C. INTRON A also is approved in Japan for use as monotherapy for hepatitis C, hepatitis B and several cancer indications. PEG-INTRON is a longer-acting form of INTRON A that uses proprietary PEG technology developed by Enzon, Inc. (Nasdaq: ENZN) of Bridgewater, N.J. PEG-INTRON, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy that is designed to achieve an effective balance between antiviral activity and elimination half-life. Schering-Plough holds an exclusive worldwide license to PEG-INTRON. INTRON A is a recombinant version of naturally occurring alpha interferon, which has been shown to exert both antiviral and immunomodulatory effects. Schering-Plough markets INTRON A for 16 major antiviral and anticancer indications worldwide. REBETOL is an oral formulation of ribavirin, a synthetic nucleoside analog. Schering-Plough has worldwide rights to market oral ribavirin for hepatitis C through a licensing agreement with Valeant Pharmaceuticals International (NYSE: VRX), formally ICN Pharmaceuticals, of Costa Mesa, Calif. DISCLOSURE NOTICE: The information in this press release includes certain " forward-looking " statements concerning PEG-INTRON and the regulatory process in Japan, the market for drugs to treat hepatitis C and Schering-Plough's products. Forward-looking statements are subject to risks and uncertainties, which may cause actual results to differ materially. These risks and uncertainties include product availability, current and future branded, generic and OTC competition, the regulatory process for new products and new indications, market acceptance of new products and new indications, timing of trade buying, and patent positions. For further details and a discussion of these and other risks and uncertainties, see the company's past and future Securities and Exchange Commission filings, including the company's 2003 10-K filed Feb. 26, 2004. Schering-Plough K.K., based in Osaka, is a wholly owned subsidiary of Schering-Plough Corporation, a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide. SOURCE Schering-Plough Corporation Web Site: http://www.schering-plough.com Company News On Call: Company News On-Call: http://www.prnewswire.com/comp/777050.html Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 22, 2004 Report Share Posted April 22, 2004 Schering-Plough Submits New Drug Application (J-NDA) in Japan for PEG-INTRON® and REBETOL® Combination Therapy for Hepatitis C KENILWORTH, N.J., April 21 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that Schering-Plough K.K., the company's subsidiary in Japan, has submitted a New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) seeking marketing approval for PEG-INTRON® (peginterferon alfa-2b) Powder for Injection for use in combination with REBETOL® (ribavirin) Capsules for the treatment of chronic hepatitis C. The MHLW will provide a priority review of the application. If approved, PEG-INTRON and REBETOL will be the first and only pegylated interferon-based combination therapy approved in Japan for treating chronic hepatitis C. Hepatitis C is estimated to affect some 2 million people in Japan, according to MHLW. It is the leading cause in Japan of chronic liver disease, cirrhosis and hepatocellular carcinoma, and is associated with more than 30,000 deaths there annually. Hepatitis C is the most common reason for liver transplant in major world markets, including Japan, according to a study conducted by the World Health Organization (WHO). Schering-Plough K.K. currently markets REBETOL in Japan for use in combination with INTRON® A (interferon alfa-2b, recombinant) Injection for chronic hepatitis C. INTRON A also is approved in Japan for use as monotherapy for hepatitis C, hepatitis B and several cancer indications. PEG-INTRON is a longer-acting form of INTRON A that uses proprietary PEG technology developed by Enzon, Inc. (Nasdaq: ENZN) of Bridgewater, N.J. PEG-INTRON, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy that is designed to achieve an effective balance between antiviral activity and elimination half-life. Schering-Plough holds an exclusive worldwide license to PEG-INTRON. INTRON A is a recombinant version of naturally occurring alpha interferon, which has been shown to exert both antiviral and immunomodulatory effects. Schering-Plough markets INTRON A for 16 major antiviral and anticancer indications worldwide. REBETOL is an oral formulation of ribavirin, a synthetic nucleoside analog. Schering-Plough has worldwide rights to market oral ribavirin for hepatitis C through a licensing agreement with Valeant Pharmaceuticals International (NYSE: VRX), formally ICN Pharmaceuticals, of Costa Mesa, Calif. DISCLOSURE NOTICE: The information in this press release includes certain " forward-looking " statements concerning PEG-INTRON and the regulatory process in Japan, the market for drugs to treat hepatitis C and Schering-Plough's products. Forward-looking statements are subject to risks and uncertainties, which may cause actual results to differ materially. These risks and uncertainties include product availability, current and future branded, generic and OTC competition, the regulatory process for new products and new indications, market acceptance of new products and new indications, timing of trade buying, and patent positions. For further details and a discussion of these and other risks and uncertainties, see the company's past and future Securities and Exchange Commission filings, including the company's 2003 10-K filed Feb. 26, 2004. Schering-Plough K.K., based in Osaka, is a wholly owned subsidiary of Schering-Plough Corporation, a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide. SOURCE Schering-Plough Corporation Web Site: http://www.schering-plough.com Company News On Call: Company News On-Call: http://www.prnewswire.com/comp/777050.html Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 22, 2004 Report Share Posted April 22, 2004 Schering-Plough Submits New Drug Application (J-NDA) in Japan for PEG-INTRON® and REBETOL® Combination Therapy for Hepatitis C KENILWORTH, N.J., April 21 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that Schering-Plough K.K., the company's subsidiary in Japan, has submitted a New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) seeking marketing approval for PEG-INTRON® (peginterferon alfa-2b) Powder for Injection for use in combination with REBETOL® (ribavirin) Capsules for the treatment of chronic hepatitis C. The MHLW will provide a priority review of the application. If approved, PEG-INTRON and REBETOL will be the first and only pegylated interferon-based combination therapy approved in Japan for treating chronic hepatitis C. Hepatitis C is estimated to affect some 2 million people in Japan, according to MHLW. It is the leading cause in Japan of chronic liver disease, cirrhosis and hepatocellular carcinoma, and is associated with more than 30,000 deaths there annually. Hepatitis C is the most common reason for liver transplant in major world markets, including Japan, according to a study conducted by the World Health Organization (WHO). Schering-Plough K.K. currently markets REBETOL in Japan for use in combination with INTRON® A (interferon alfa-2b, recombinant) Injection for chronic hepatitis C. INTRON A also is approved in Japan for use as monotherapy for hepatitis C, hepatitis B and several cancer indications. PEG-INTRON is a longer-acting form of INTRON A that uses proprietary PEG technology developed by Enzon, Inc. (Nasdaq: ENZN) of Bridgewater, N.J. PEG-INTRON, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy that is designed to achieve an effective balance between antiviral activity and elimination half-life. Schering-Plough holds an exclusive worldwide license to PEG-INTRON. INTRON A is a recombinant version of naturally occurring alpha interferon, which has been shown to exert both antiviral and immunomodulatory effects. Schering-Plough markets INTRON A for 16 major antiviral and anticancer indications worldwide. REBETOL is an oral formulation of ribavirin, a synthetic nucleoside analog. Schering-Plough has worldwide rights to market oral ribavirin for hepatitis C through a licensing agreement with Valeant Pharmaceuticals International (NYSE: VRX), formally ICN Pharmaceuticals, of Costa Mesa, Calif. DISCLOSURE NOTICE: The information in this press release includes certain " forward-looking " statements concerning PEG-INTRON and the regulatory process in Japan, the market for drugs to treat hepatitis C and Schering-Plough's products. Forward-looking statements are subject to risks and uncertainties, which may cause actual results to differ materially. These risks and uncertainties include product availability, current and future branded, generic and OTC competition, the regulatory process for new products and new indications, market acceptance of new products and new indications, timing of trade buying, and patent positions. For further details and a discussion of these and other risks and uncertainties, see the company's past and future Securities and Exchange Commission filings, including the company's 2003 10-K filed Feb. 26, 2004. Schering-Plough K.K., based in Osaka, is a wholly owned subsidiary of Schering-Plough Corporation, a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide. SOURCE Schering-Plough Corporation Web Site: http://www.schering-plough.com Company News On Call: Company News On-Call: http://www.prnewswire.com/comp/777050.html Quote Link to comment Share on other sites More sharing options...
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